Vulvovaginal CandidiasisPhase 3NCT02907307
Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
A Phase 3 study testing LactiSal vaginal gel 1%, LactiSal vaginal tablet 50mg and Clotrimazole vaginal tablet 100mg in people with Vulvovaginal Candidiasis, run by Medinova AG.
Trial summary
The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- LactiSal vaginal gel 1%, LactiSal vaginal tablet 50mg and Clotrimazole vaginal tablet 100mg
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs \& symptoms of VVC as Total Severity Score, TSC 4 (range 0-15):
- vaginal itching (range 0-3) ,
- vaginal burning or soreness (range 0-3),
- abnormal vaginal discharge (range 0-3),
- vulvo/vaginal erythema or oedema (range 0-3),
- vulvar excoriation or fissure formation (range 0-3).
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- Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts
- Normal vaginal pH (≤4.5)
- Age: 18 years and older
- Signed Written Informed Consent to participate in this study.
Who cannot join
- Recurrent VVC (4 episodes of VVC in the past 12 months).
- Women with other vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections.
- Women using oral or vaginal antifungals within 2 weeks prior to enrolment.
- Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment.
- Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
- Women having menstruation bleeding at enrolment
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- Cervicitis, cervical erosions, and malignant tumours in the genital tract
- Pregnancy or lactation.
- Women not consenting to be sexually abstinent during the treatment, not taking oral contraceptive or not having an IUD for contraception
- Woman using intravaginal pessaries, rings, sponges or diaphragms
- Severe systemic diseases (diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.).
- Women with confirmed or suspected STD (HIV infection, gonorrhoea, syphilis, chlamydiasis, etc.).
- Known or suspected hypersensitivity to one of the study medications, inclusive their excipients.
- Participation of patient in another clinical study concomitantly or within 30 days prior to enrolment
- Patient is relative of, or staff directly reporting to, the investigator.
About this study
Official title: Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)
The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)
Read the detailed description
National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1.
The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims:
- Treatment of vaginal yeast vaginitis
- Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis
- Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets.
While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a "mixed" study, comparing the efficacy of a medical device with a pharmaceutical product.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- LactiSal vaginal gel 1%, LactiSal vaginal tablet 50mg, Clotrimazole vaginal tablet 100mg
- Keywords
- LactiSal, Vaginal therapy
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactiSal vaginal gel 1%Device
to be administered daily intravaginally for 6 days
LactiSal vaginal tablet 50mgDevice
to be administered daily intravaginally for 6 days
Clotrimazole vaginal tablet 100mgDrug
Also called Candibene
to be administered daily intravaginally for 6 days
| Study group | Role | What they receive |
|---|---|---|
| LactiSal vaginal gel 1% | Experimental | 5g of 1%LactiSal Gel vaginal gel once daily for 6 days Receives: Device: LactiSal vaginal gel 1% |
| LactiSal vaginal tablet 50 mg | Experimental | 50 mg of LactiSal vaginal tablet daily for 6 days Receives: Device: LactiSal vaginal tablet 50mg |
| Clotrimazole vaginal tablet 100mg | Active comparator | 100 mg Clotrimazole vaginal tablet daily for 6 days Receives: Drug: Clotrimazole vaginal tablet 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.
Measured: 10 days after entry (C1)
Secondary outcomes (11)
Clinical cure rate
Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.
Measured: 4 weeks after control visit 1
Microbiological cure rate
Negative for Candida in microscopy and culture
Measured: 10 days after entry visit and 4 weeks after control visit 1
Therapeutic cure rate
Clinically and microbiologically cure combined
Measured: 10 days after entry visit and 4 weeks after control visit 1
The Total Severity Score (TSC) Individual clinical signs and symptoms
The TCS assessed by the investigator
- vaginal itching (range 0-3)
- vaginal burning or soreness (range 0-3)
- abnormal vaginal discharge (range 0-3)
- vulvo/vaginal erythema or oedema (range 0-3)
- vulvar excoriation or fissure formation (range 0-3)
Measured: 10 days after entry visit and 4 weeks after control visit 1
Dyspareunia and external dysuria
Presence of dyspareunia and external dysuria (yes/no)
Measured: 10 days after entry visit and 4 weeks after control visit 1
Direct microscopy (Wet smear)
Number of positive findings in Direct microscopy (Wet smear) in comparison to visit E
Measured: 10 days after entry visit and 4 weeks after control visit 1
pH
Mean vaginal pH in comparison to visit E
Measured: 10 days after entry visit and 4 weeks after control visit 1
Candida culture
Number of positive Candida cultures in comparison to visit E
Measured: 10 days after entry visit and 4 weeks after control visit 1
Efficacy assessment
Global assessment of efficacy by patient and investigator
Measured: 10 days after entry visit and 4 weeks after control visit 1
Patients diary
Assessment clinical symptoms from patient?s diary
Measured: 10 days after entry visit and 4 weeks after control visit 1
Patient's satisfaction
Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.
Measured: 10 days after entry visit and 4 weeks after control visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Why it stopped: Development project stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Halaška, MD, Principal investigator, Nemocnice Bulovka, 1. LF UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907307
- Sponsor's protocol ID
- LacS011
- Status last verified
- Dec 2017
- First submitted
- 23 Sep 2015
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)
- ClinicalTrials.gov ID
- NCT02907307
- Acronym / sponsor ID
- LacS011
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- LactiSal, Vaginal therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development project stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medinova AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of LactiSal 1%vaginal gel and LactiSal 50 mg vaginal tablet with the standart treatment of clotrimazole 100 mg vaginal tablet in woman with vulvovaginal candidiasis (VVC)
Detailed description
National multicenter,randomized, open-label, active-controlled with three parallel groups.Eligible patients are randomized to receive LactiSal 1% vaginal gel, LactiSal 50 mg vaginal tablet or clotrimazole 100 mg vaginal tablet for 6 days. Control examaminations are performed 10 after entry and 4 weeks after control visit 1.
The study investigates the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50mg vaginal tablets in the intended use, i.e. vaginal application, and the following intended claims:
- Treatment of vaginal yeast vaginitis
- Relieves vaginal itching, burning, redness and discharge in case of yeast vaginitis
- Inhibition of yeast colonization in the vagina in case of yeast vaginitis. The study is designed to compare the clinical efficacy and safety of Lactisal 1% vaginal gel and LactiSal 50 mg vaginal tablets to a current standard drug therapy, i.e. clotrimazole 100 mg vaginal tablets.
While LactiSal is classified as medical device class IIa, the comparator is a medicinal (pharmaceutical) product. The study represents a "mixed" study, comparing the efficacy of a medical device with a pharmaceutical product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LactiSal vaginal gel 1% | Experimental | Device: LactiSal vaginal gel 1%5g of 1%LactiSal Gel vaginal gel once daily for 6 days |
| LactiSal vaginal tablet 50 mg | Experimental | Device: LactiSal vaginal tablet 50mg50 mg of LactiSal vaginal tablet daily for 6 days |
| Clotrimazole vaginal tablet 100mg | Active comparator | Drug: Clotrimazole vaginal tablet 100mg100 mg Clotrimazole vaginal tablet daily for 6 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical signs \& symptoms of VVC as Total Severity Score, TSC 4 (range 0-15):
- Direct microscopy (Wet smear) positive for yeast forms (hyphae, pseudohyphae) or budding yeasts
- Normal vaginal pH (≤4.5)
- Age: 18 years and older
- Signed Written Informed Consent to participate in this study.
Key exclusion criteria (15 listed)
- Recurrent VVC (4 episodes of VVC in the past 12 months).
- Women with other vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections.
- Women using oral or vaginal antifungals within 2 weeks prior to enrolment.
- Women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment.
- Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactiSal vaginal gel 1%to be administered daily intravaginally for 6 days | Device | LactiSal vaginal gel 1% |
| LactiSal vaginal tablet 50mgto be administered daily intravaginally for 6 days | Device | LactiSal vaginal tablet 50 mg |
| Clotrimazole vaginal tablet 100mgAlso: Candibeneto be administered daily intravaginally for 6 days | Drug | Clotrimazole vaginal tablet 100mg |
Primary outcome
Clinical cure rate
Time frame: 10 days after entry (C1)
Clinical cure is defined as patient having a Total Severity Score of less than 3. The Total Severity Score (TSC) is assessed by the Investigator, examining and interviewing the patient. The TSC is the sum score of the 5 individual signs symptoms - vaginal itching, vaginal burning or soreness, abnormal vaginal discharge, vulvovaginal erythema or oedema and vulval excoriation or fissure formation. Each sign and symptom is assessed with a score from 0 to 3, resulting in total score for TSC of 0 to 15.
11 secondary outcomes
Clinical cure rate
Time frame: 4 weeks after control visit 1
Microbiological cure rate
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Therapeutic cure rate
Time frame: 10 days after entry visit and 4 weeks after control visit 1
The Total Severity Score (TSC) Individual clinical signs and symptoms
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Dyspareunia and external dysuria
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Direct microscopy (Wet smear)
Time frame: 10 days after entry visit and 4 weeks after control visit 1
pH
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Candida culture
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Efficacy assessment
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Patients diary
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Patient's satisfaction
Time frame: 10 days after entry visit and 4 weeks after control visit 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Halaška, MD principal investigator
Nemocnice Bulovka, 1. LF UK
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LactiSal vaginal gel 1%, LactiSal vaginal tablet 50mg and Clotrimazole vaginal tablet 100mg in people with Vulvovaginal Candidiasis, run by Medinova AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: 10 days after entry (C1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.